Immediate opportunities for Quality Systems & Distribution Specialists to support the QA Central Services Team. Do you have a strong QA / GMP background to support with documentation release process, and working with CMOs / CDMOs?
This position is open to both REMOTE and onsite candidates. Apply today!
Schedule Shift : 1st shift, Wed.-Sat., 4x10 schedule, 8am-6pm (flexible). Additional OT may be needed on Sunday during July and August.
Position Type : Contract role for 6 mos. (through Dec 2024); extension possible up to 18 mos.
Pay Rate : $45-60 / hr. for Onsite and $35-$47 / hr. for Remote
Essential Duties and Responsibilities :
- Perform the release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps.
- Conduct batch record review as needed
- Administration support for documentation archive in Veeva eQMS
- Ensure compliance with required training
- Resolve issues with CMO documentation in collaboration with CS leads and CMO leads
- Depending on skill set and previous experience, there may be need to rotate to support Compliance, operational excellence project work and / or quality project management teams.
Qualifications :
- Sr. Specialist level (5+ years experience)
- Excellent communication skills
- Proficiency in regulatory requirements
- Familiarity in Veeva systems or similar quality document management
- Experience performing batch record review and batch disposition
- Familiarity in Drug Product GMP Manufacturing
Quality Systems & Distribution Specialist - REMOTE or Onsite
Immediate opportunities for Quality Systems & Distribution Specialists to support the QA Central Services Team. Do you have a strong QA / GMP background to support with documentation release process, and working with CMOs / CDMOs? This position is open to both REMOTE and onsite candidates. Depending...
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